MHI-TM2000 Linear Accelerator System, VERO, Imavis— 510(k) K152867

Substantially Equivalent

Mitsubishi Heavy Industries, Ltd.

FDA 510(k) clearance K152867 for MHI-TM2000 Linear Accelerator System, VERO, Imavis, Substantially Equivalent on 2015-10-21. Applicant: Mitsubishi Heavy Industries, Ltd..

Clearance details

Applicant: Mitsubishi Heavy Industries, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2015-09-30
Decision date: 2015-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hiroshima-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.